MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MONOPTY; BIOPSY INSTRUMENT

Model Number 121410

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2023

Event Type  malfunction  

Event Description

It was reported that prior to opening the package, a red foreign material was allegedly confirmed in the package.There was no reported patient involvement.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2025).H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that prior to opening the package, a red foreign material was allegedly found in the package.The procedure was completed using another device.There was no patient involvement.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one sealed monopty disposable biopsy instrument was returned for evaluation.On visual evaluation, the device appeared to be clean and it was noted that red foreign material was within the packaging.Also, two electronic photos were provided for review.The two photos shows the sealed monopty device where the red color foreign material was noted to the back of the device.Therefore, based on the photo review, the reported failure device contamination with chemical or other material can be confirmed.Based on the sample evaluation and photo review, the investigation for the reported device contamination with chemical or other material is confirmed as the foreign material was noted.A definitive root cause for the alleged device contamination with chemical or other material could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiry date: 08/2025), g3.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: MONOPTY
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17315266
• MDR Text Key: 319034832
• Report Number: 2020394-2023-00519
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741084584
• UDI-Public: (01)00801741084584
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 121410
• Device Catalogue Number: 121410
• Device Lot Number: REGW3331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1